Non-drug Study to Evaluate the Suitability of Neurocognitive Tests and Functioning Scales for the Measurement of Cognitive and Functioning Changes in Children With Down Syndrome



Status:Completed
Conditions:Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:6 - 11
Updated:10/27/2017
Start Date:June 2, 2015
End Date:June 30, 2016

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A Multicenter, Longitudinal, Non-drug Study to Assess the Suitability of Neurocognitive Tests and Functioning Scales for the Measurement of Cognitive and Functioning Changes in Children With Down Syndrome

The aim of this study is to assess the suitability of selected scales (floor/ceiling effects,
variability, test-retest reliability) to measure cognitive function in children with Down
syndrome over 6 months, and to evaluate the influence of covariates such as age, gender or
language on these neurocognitive scales.


Inclusion Criteria:

- Males and females aged 6 to 11 with diagnosis of Down syndrome (Trisomy 21). Children
may have standard trisomy 21, Robertsonian translocation, isochromosome 21 (so called
21q21q Robertsonian translocation), Down syndrome with reciprocal translocation or
mosaicism.

- Down syndrome children meeting clinical diagnostic criteria for generalized anxiety
disorders, autism spectrum disorder, attention deficit and hyperactivity disorder, can
participate in the study provided they are considered clinically stable or on stable
medication for at least 8 weeks prior to the baseline visit.

- Parent or legal guardian/representative and caregiver willing to give written informed
consent.

- Subjects with sufficient vision and hearing to engage in study evaluations as referred
by their parents. Mild hearing loss will be allowed.

Exclusion Criteria:

- Children who may not be able to comply with the protocol or perform the outcome
measures due to significant hearing or visual impairment or other issues judged
relevant by the investigators

- Significant sleep disruption or moderate to severe untreated obstructive sleep apnea.

- Any condition which would make the individual or the caregiver, in the opinion of the
investigator, unsuitable for the study.
We found this trial at
4
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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2400 Pratt Street
Durham, North Carolina 27710
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Tucson, Arizona 85721
(520) 621-2211
University of Arizona The University of Arizona is a premier, public research university. Established in...
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